326 / Reducing Risks for Mental Disorders
METHODOLOGICAL RESEARCH ISSUES
Treatment research has advanced in the past decade througl of rigorous, controlled clinical trial methodology (Karasu, 199' have been carefully designed, conducted, and analyzed. The has been hypothesis-driven, including a focus on the role of protective factors in the onset and course of the disorder (Li 1986). When treatment trials have concluded, patients have 1 lowed up to determine the full effects of the intervention.
Treatment fidelity has been improved through the use of o] alized therapy manuals (Liberman, 1993). Until treatment progressed to the point where therapy manuals became prerequ NIMH funding, it was impossible to compare the results of s psychotherapy conducted by different investigators, therapi academic centers. With the advent of these manuals, therapi: ensure fidelity of the subsequent replication and coopera collaborative multisite studies (Wallace, Liberman, MacKain, B and Eckman, 1992).
Many of these same research principles are being applied to tion trials. Preventive intervention research should be hy] driven, with specification of the linkages and intervening mec through which the interventions are expected to affect identi and protective factors and mediate delay or prevention of d Participants in prevention trials should be followed up for lon£ periods to determine the full effects of the intervention on the able disorder(s). Fidelity can be increased through the use specified and replicable written manuals that clearly spell c aspects of the intervention can be adapted to meet the needs of cultural, socioeconomic, and age groups.
ETHICAL AND CULTURAL CONSIDERATIONS
In the design of an intervention program, and of the methodology necessary to test its efficacy and effectiveness, c needed to guard against unintended negative effects. A pillar in delivery of health care is "do no harm." Unfortunately, t research has resulted in examples of untoward iatrogenic effe both pharmacological and psychosocial interventions (Flana Liberman, 1982; Gutheil and Appelbaum, 1982). The mecha action and long-term effects and side effects of many of our cological and psychosocial treatments remain to be clarified particularly true during childhood, when many biological, pss for a depressed mother might reduce the emotional risks for her child. Similarly, preventive interventions with a parent, sibling, or child might also reduce risks for other family members, but unless these potential positive "side effects" are anticipated, opportunities to measure them will be lost.situations with peers on the playground);